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NCT00997984 · ClinicalTrials.gov registry record · Phase 3
Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 340
- Enrollment target
NCT00997984: Completed Phase 3 study, sponsored by Shire.
NCT00997984 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 340 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00997984, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 340 participants
- Enrollment target
Study Summary
The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
Primary Outcome
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Interventions
- DRUG placebo
- DRUG extended-release guanfacine hydrochloride (SPD503)
- DRUG extended-release guanfacine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2009-11-17 |
| Est. Completion | 2010-10-09 |
| Phase | Phase 3 |
What the finished NCT00997984 record still lists
NCT00997984 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00997984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00997984 about?
NCT00997984 is a clinical study titled "Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)". The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
What is the current status of trial NCT00997984?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 340 participants. The study started on 2009-11-17. Estimated completion is 2010-10-09.
What interventions are being tested in trial NCT00997984?
The interventions under investigation include: placebo (DRUG), extended-release guanfacine hydrochloride (SPD503) (DRUG), extended-release guanfacine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00997984?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00997984's enrollment target sits among peer trials
340 1053rd of 2000 higher than 945 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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